PMID- 31228628
OWN - NLM
STAT- MEDLINE
DCOM- 20200217
LR  - 20200217
IS  - 1534-4436 (Electronic)
IS  - 1081-1206 (Linking)
VI  - 123
IP  - 3
DP  - 2019 Sep
TI  - Tolerability of Ig20Gly during onboarding in patients with primary 
      immunodeficiency diseases.
PG  - 271-279.e1
LID - S1081-1206(19)30436-3 [pii]
LID - 10.1016/j.anai.2019.06.004 [doi]
AB  - BACKGROUND: The subcutaneous immune globulin (SCIG) 20% product, Ig20Gly, was 
      shown to be efficacious and well tolerated in 2 phase 2/3 North American and 
      European studies at infusion volumes up to 60 mL/site and rates up to 60 
      mL/h/site in patients with primary immunodeficiency diseases. OBJECTIVE: To 
      assess patient experience after switching to Ig20Gly with fast infusion rates and 
      large infusion volumes/site in the North American study. METHODS: In this 
      analysis of the open-label phase 2/3 study in which patients aged >/=2 years 
      received weekly Ig20Gly infusions for up to approximately 1.3 years, tolerability 
      and infusion parameters were assessed throughout the study for all patients and 
      by prestudy treatment regimen (intravenous [IV] switchers or SC switchers). 
      RESULTS: Overall, 61% of patients reached the infusion rate of >/=60 mL/h/site and 
      continued at this rate for 1 or more subsequent infusions; the median infusion 
      number when patients first reached >/=60 mL/h/site was 3. No association was found 
      between higher infusion volumes or rates and increased incidences of local and 
      systemic adverse events (AEs) in the total population and patients younger than 
      16 years. Infusion parameters and tolerability were generally comparable 
      regardless of the route of prestudy treatment (IV or SC switchers); however, IV 
      switchers experienced lower rates of local AEs than SC switchers and had a 
      slightly higher median infusion volume per site and longer infusion duration vs 
      SC switchers. CONCLUSION: High Ig20Gly infusion rates of at least 60 mL/h/site 
      and volumes >/=60 mL/site were well tolerated during onboarding and throughout 
      treatment, regardless of prestudy treatment. TRIAL REGISTRATION: 
      ClinicalTrials.gov Identifier NCT01218438.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Gupta, Sudhir
AU  - Gupta S
AD  - University of California at Irvine, Irvine, California.
FAU - Stein, Mark
AU  - Stein M
AD  - Allergy Associates of the Palm Beaches, North Palm Beach, Florida.
FAU - Hussain, Iftikhar
AU  - Hussain I
AD  - Allergy, Asthma, and Immunology Center, Tulsa, Oklahoma.
FAU - Paris, Kenneth
AU  - Paris K
AD  - LSU Health Sciences Center, Children's Hospital of New Orleans, New Orleans, 
      Louisiana.
FAU - Engl, Werner
AU  - Engl W
AD  - The Takeda group of companies, Vienna, Austria.
FAU - McCoy, Barbara
AU  - McCoy B
AD  - The Takeda group of companies, Vienna, Austria.
FAU - Rabbat, Christopher J
AU  - Rabbat CJ
AD  - The Takeda group of companies, Chicago, Illinois.
FAU - Yel, Leman
AU  - Yel L
AD  - University of California at Irvine, Irvine, California; The Takeda group of 
      companies, Cambridge, Massachusetts. Electronic address: leman.yel@takeda.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01218438
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20190620
PL  - United States
TA  - Ann Allergy Asthma Immunol
JT  - Annals of allergy, asthma & immunology : official publication of the American 
      College of Allergy, Asthma, & Immunology
JID - 9503580
RN  - 0 (Immunoglobulins)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Child
MH  - Child, Preschool
MH  - Drug Tolerance/*immunology
MH  - Female
MH  - Humans
MH  - Immunoglobulins/*therapeutic use
MH  - Immunotherapy/*methods
MH  - Infusions, Subcutaneous/*methods
MH  - Male
MH  - Middle Aged
MH  - North America
MH  - Primary Immunodeficiency Diseases/immunology/*therapy
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2019/06/23 06:00
MHDA- 2020/02/18 06:00
CRDT- 2019/06/23 06:00
PHST- 2018/12/13 00:00 [received]
PHST- 2019/06/12 00:00 [revised]
PHST- 2019/06/13 00:00 [accepted]
PHST- 2019/06/23 06:00 [pubmed]
PHST- 2020/02/18 06:00 [medline]
PHST- 2019/06/23 06:00 [entrez]
AID - S1081-1206(19)30436-3 [pii]
AID - 10.1016/j.anai.2019.06.004 [doi]
PST - ppublish
SO  - Ann Allergy Asthma Immunol. 2019 Sep;123(3):271-279.e1. doi: 
      10.1016/j.anai.2019.06.004. Epub 2019 Jun 20.